Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Proteus 235 Proton Therapy System for cancer treatment. Recalled by Ion Beam Applications S.A. Due to While the Proteus 235 is in the pencil...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ion Beam Applications S.A. directly.
Affected Products
Proteus 235 Proton Therapy System for cancer treatment.
Quantity: 8
Why Was This Recalled?
While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ion Beam Applications S.A.
Ion Beam Applications S.A. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report